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Not yet recruiting NCT07449299

Rct Assessing Pregnancy - Piroxicam for Ec With Levonorgestrel

Phase III Interventional Emergency Contraception Contraception COX-2 Inhibitor

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Levonorgestrel 1.5 mg and Piroxicam 40 mg, Oral LNG + Placebo.
Who it may be relevant to
Registry conditions: Emergency Contraception, Contraception, COX-2 Inhibitor. Basic parameters: 16 years — 35 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

This randomized controlled trial will test oral levonorgestrel + piroxicam vs. levonorgestrel + placebo for emergency contraception in a representative U.S. population that has higher pregnancy risk than in the prior study because of higher weights, different intercourse patterns, and different clinic accessibility. Data from this project will inform clinical practice in the U.S. and beyond for those desiring the most effective method of emergency contraception pills.

Interventions

  • Drug Levonorgestrel 1.5 mg and Piroxicam 40 mg
    The study intervention is a combination of Levonorgestrel 1.5 mg and Piroxicam 40 mg for emergency contraception. Participants will be randomized 3:1 to this vs. Levonorgestrel 1.5 mg and placebo.
  • Drug Oral LNG + Placebo
    The study intervention is a combination of Levonorgestrel 1.5 mg and placebo for emergency contraception. Participants will be randomized 3:1 to Levonorgestrel 1.5 mg and Piroxicam vs. this option.

Primary outcome measures

  • EC efficacy between the two study groups measured by pregnancy status four weeks after EC use. [Time frame: One month after consuming study drug]
Secondary outcome measures (2)
  • Pregnancy risk for participants weighing ≥75 kg compared between the two drug treatment groups. [Time frame: One month after consuming study drug]
  • Test hypothesis that LNG + piroxicam will yield superior proportion of pregnancies prevented among participants using EC on the day of ovulation and post-ovulation compared to LNG + placebo. [Time frame: One month after consuming study drug.]

Eligibility criteria

Inclusion criteria

  • Between 16-35 years old and desire LNG for EC
  • Unprotected intercourse within 72 hours
  • Biologically capable of pregnancy
  • Regular menstrual cycle 21-35 days long with known LMP +/- 3 days
  • Working cell phone number that receives text messages (for Aim 3 participants phone with capability to download and use the Oova application and submit data)
  • Fluent in English and/or Spanish
  • Willing to comply with the study requirements including 1-month urine pregnancy test
  • No known contraindications to oral LNG or piroxicam - For secondary outcome assessing pregnancy risk for participants receiving study drug on day of ovulation or later - are currently using a menstrual cycle tracking application and can demonstrate according to the application that they are on the day of ovulation or post ovulation.

Exclusion criteria

  • Current pregnancy (+urine pregnancy test in clinic)
  • Breastfeeding, post abortion or postpartum without resuming menstruation
  • Use of hormonal contraception (including oral EC) within seven days of enrollment
  • Use of NSAIDs (ibuprofen, naproxen, celecoxib, diclofenac, aspirin) in the prior week
  • Highly effective contraception including permanent contraception (including partner with vasectomy), IUD, or contraceptive implant
  • Allergy to LNG or piroxicam
  • Desires UPA for EC

History of stroke, myocardia infarction, ischemic heart disease, uncontrolled hypertension, congestive heart failure, peptic ulcer disease, renal or hepatic failure. Currently taking anticoagulants, corticosteroids, cyclosporine, lithium, methotrexate, or tacrolimus.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Li RHW, Lo SST, Gemzell-Danielsson K, Fong CHY, Ho PC, Ng EHY. Oral emergency contraception with levonorgestrel plus piroxicam: a randomised double-blind placebo-controlled trial. Lancet. 2023 Sep 9;402(10405):851-858. doi: 10.1016/S0140-6736(23)01240-0. Epub 2023 Aug 16. PMID 37597523

Identifiers

NCT: NCT07449299 · 00180510

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗